A Volunteer Study to Collect Imaging Data for the Development of the IntelligentUltrasound Anatomy Guide

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04277169

Enrollment

150

Registered

2020-02-20

Start date

2020-02-01

Completion date

2020-09-01

Last updated

2021-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasound Imaging of Anatomical Structures

Brief summary

This is a single-centre, prospective, non-randomised volunteer study to be undertaken in the MediCentre, Heath Park, Cardiff, UK

Detailed description

This is a single-centre, non-randomised, prospective study involving at least 120 participants. The data collected in this study will augment the data collected in IU2019\_AG\_03 Volunteers will be enrolled sequentially until at least 120 scans have been recorded. Ideally, between 120 and 150 scans will be recorded. Phase I Data collected from up to the first 80 participants in each of the six peripheral nerve block areas will be used as a training/verification set. This set will be used to develop and verify models for the identification and highlighting of target anatomical structures on ultrasound images. Phase II The remaining 40 videos in each area (total minimum 120 participants) will be used for validation of these models. The validation videos will be fed into the models created during Phase I of the study and the output anatomy highlighting will be recorded as a separate video, overlaid on the original ultrasound image. The overlay video will then be further split into 30-second segments. A panel of three independent expert anaesthetists will be convened to review and score the segments for accuracy and performance to the endpoints agreed in Phase I of the study.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Male or female, at least 18 years of age; 2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion criteria

1. Aged \<18 years of age; 2. Unwilling or unable to provide informed consent.

Design outcomes

Primary

Measure	Time frame	Description
Model development and verification	4 months	Collection of ultrasound scans. The collected scans will be assessed and used in the development and verification of deep-learning models that identify the target structures using a training dataset.

Secondary

Measure	Time frame	Description
Model validation	4 months	Estimation of performance and accuracy (e.g. success/failure of highlighting of target structures, average distance of highlighting from target, time spent highlighting correct structure as a proportion of time target visible)

Countries

United Kingdom

Outcome results